1. Slides compiled by Dr. Najma Ahmed
A treat to target approach decreases the rate of CD-related adverse outcomes versus a clinical approach in patients with moderate to severely active Crohn’s disease: Data from CALM
Colombel J, Panaccione R, Bossuyt P, et al.
Slides compiled by Dr. Najma Ahmed
UEGW 2017

2. Introduction Background and objectives Methods
Primary results of CALM showed a treat-to-target (T2T) approach led to superior endoscopic and deep remission vs standard clinical management (CM) in CD1,2
Objective: To assess adverse outcomes (e.g., hospitalizations) in CALM
Methods
N=244 (122 in CM, 122 in T2T), baseline characteristics similar between groups
Mean age ± SD, 31.6 ± 11.7 years; mean CD duration ± SD, 0.95 ± 1.98 years
Treatment at randomization and at Weeks 11, 23 and 35 based on failure to fulfil success criteria: CDAI < 150, CRP < 5 mg/L, FC < 250 mg/g, no prednisone use
T2T: Escalation driven by CDAI, FC, CRP, prednisone use
CM: Escalation driven by CDAI, prednisone use
Further details about methodology are available in the DDW 2017 CALM summary2
CD: Crohn’s disease; CDAI: Crohn’s Disease Activity Index; CRP: C-reactive protein; FC: fecal calprotectin; SD: standard deviation 1. Colombel JF, et al. Lancet 2017; DOI: /S (17)
2. IBD Update. Treat to target vs clinical management in CD: CALM. DDW Summary slides available here.

3. Method Endpoints evaluated at 48 weeks after randomization Endpoint
Description
CD-related hospitalization*
On or after randomization and ≤ 70 days after last dose
CD-related surgical procedure
Major: Bowel resection, ostomy, by-pass, strictureplasty, surgical drainage of abdominal/pelvic abscess
Non-major: Debridement, abscess drainage, seton placement, fistulotomy, TPN access line
CD-related hospitalization* OR serious complication
CD-related hospitalization OR
Abscess, fistula or stricture, skin or ocular EIM, or serious adverse drug reaction (from randomization up to Week 48 or last dose)
Time to CD-related flare
Time to increase in CDAI ≥ 70 points from 1 week prior to randomization OR early randomization CDAI and CDAI > 220
*Other than for CD-related major surgery
CDAI: Crohn’s Disease Activity Index; EIM: extra-intestinal manifestation; TPN: total parenteral nutrition

4. Rates of CD-related hospitalizations after randomization
Results
Compared with clinical management, treat to target was associated with significant reductions in:
CD-related hospitalizations
Time to CD-related flare (next slide)
No significant difference:
CD-related surgical procedure
CD-related hospitalizations or serious complications
Rates of CD-related hospitalizations after randomization
P = 0.021
Events/100 PY
29 events
14 events
Treat to Target
N = 122
PY = 103.6
N = 122
PY = 106.3
CD: Crohn’s Disease
*CD-related hospitalization, other than CD-related major surgery, on or after randomization and ≤ 70 days after last dose.

5. Results Time to CD-related flare*
There was an early separation in the time to CD-related flare between the clinical management and T2T groups
Log-rank P=0.010
HR=0.4 95% CI , P=0.012
Proportion of patients without CD flare
Clinical Management T2T
Week after randomization
No. at risk
122 97 94 85 78 75
107
105
101 86
CD: Crohn’s Disease; T2T: treat to target
*CD-related flare: Increase in CDAI ≥ 70 points from 1 week prior to randomization OR early randomization CDAI and CDAI > 200

6. Conclusions & significance to clinical practice
A treat-to-target approach led to reduced CD-related hospitalizations and time to CD-related flare compared with standard clinical management
Significance to clinical practice
Need to correlate clinical symptoms with objective data prior to making treatment decisions
Study limitations include short-term data (1 year), new-onset disease (within 1 year) and IMM- and biologic-naive
CD: Crohn’s disease; IMM: immunomodulator